Validation Study CARES (OPSA-PK)

Hasselt University

Status: Completed

Conditions: Cancer

Treatments: Other: Questionnaire, focus group participation

Study type: Interventional

Funder types: Other

Identifiers

NCT02282696

OPSA-PK

Details and patient eligibility

About

This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs.

• QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire package participants have to fill in the CARES a second time and answer some questions to evaluate the feasibility of the CARES.
• QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage can participate in a focus group interview. In these focus groups the content validity and preferences on psychosocial screening in care are discussed.

Enrollment: 197 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary cancer diagnosis stage I, II, III
• All types of cancer

Exclusion criteria

• Having had or premorbid neurological problems or cognitive dysfunctions.
• The lack of proficiency in Dutch (Flemish).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

cancer patients

Experimental group

Description:

Questionnaire, focus group participation

Treatment:

Other: Questionnaire, focus group participation